Characterization of Co-Formulated High-Concentration Broadly Neutralizing Anti-HIV-1 Monoclonal Antibodies for Subcutaneous Administration
The number of approved monoclonal antibodies (mAbs)for therapy against various cardiovascular, cancer, respiratory, hematology, and autoimmune diseases is continuously on the rise [1].
Development of a Rapid and Efficient Lyophilization Process Indu Javeri, and K. Nellaiappan CuriRx, Inc, 205 Lowell St, Wilmington, MA 01887
Over the past several decades, lyophilization/freeze-drying has been used to produce stable drug products with a much-improved shelf-life. Lyophilization is a process of arresting water-mediated catalytic reactions.
Injectability /Viscosity Analysis for High-Concentration Monoclonal Antibody Formulations
Developing high-concentration mAb formulations (≥ 150 mg/mL) for subcutaneous delivery is now in great demand. The mAbs with high concentrations usually exhibit high viscosity and physical instability of the protein due to changes in colloidal properties resulting in aggregation.